R&D Drug-Device Combo Product Manager

ADP; New Jersey; On-site; USD 130,000 - 140,000; Full time

Benefits offered by this job

Discretionary bonus

Comprehensive benefits package

Job summary

ADP in Pinebrook, NJ, is seeking a Combination Product Manager, R&D, to lead development of drug-device combination products using strict design control and risk management processes. You will collaborate with Quality, Regulatory, Clinical, Pharmacovigilance, Project Management, and Supply Chain teams, and participate in due diligence of new products.

The role requires 5–7 years in combination product development, with expertise in design controls, DHF, ISO standards, and strong technical

Qualifications

• BS/MS in Engineering (Mechanical or Chemical) or equivalent with 5-7 years of industry experience in the development of combination products (drug & device).
• Experience with design controls and product risk management.
• Strong written and verbal communication, technical writing, and presentations.

Responsibilities

• Design and development of combination products using the design control process (in compliance with 21CFR820.30 and ISO13485:2016 section 7.3).
• Preparation, review or update of Design History File (DHF) and risk management file (in compliance with ISO 14971:2019) for the combination products
• Monitoring and review of device constituent part development at the third party design/development house(s) including design reviews and DHF documents review
• Subject matter expert for the due diligence of combination products such as injectable pens, inhalation products, transdermal products, infusions, etc.
• Contribute to the update of commercial combination product design and/or risk files, as needed.
• Partner with Third Party Quality, Combination product to ensure Design History Files and Risk Management Files are complete and compliant
• Support complaint management, pharmacovigilance, and operations to assess product risks and risk reviews.
• Keep abreast of regulatory, cGMP and QSR trends. Stay informed of FDA, EU and ICH Guidelines on drug-device combination products.

Skills

Design controls

Risk management

Technical writing

Regulatory compliance

Cross-functional collaboration

Education

BS/MS in Engineering (Mechanical or Chemical) or equivalent

Job description

ADP in Pinebrook, NJ, is seeking a Combination Product Manager, R&D, to lead development of drug-device combination products using strict design control and risk management processes. You will collaborate with Quality, Regulatory, Clinical, Pharmacovigilance, Project Management, and Supply Chain teams, and participate in due diligence of new products.

The role requires 5–7 years in combination product development, with expertise in design controls, DHF, ISO standards, and strong technical